drugset / Trial / NCT05586074
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.
Timeline
- Start
- 2023-03-03
- Primary completion
- 2027-11-30
- Completion
- 2028-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Clifutinib | Unknown | 40 mg | Oral |
| Comparator | Cytarabine | Small molecule | 10 mg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 1 g | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 2 g | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 3 g | Subcutaneous |
| Comparator | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 10 mg/m2 | Intravenous |